Regenerys Pilot Study
Research type
Research Study
Full title
A pilot study to determine the safety and efficacy of autologous adipose tissue banking in breast reconstruction following cancer.
IRAS ID
106121
Contact name
Jill Deane
Contact email
Sponsor organisation
Regenerys Ltd
Research summary
Over the last few years the demand for breast reconstruction following breast cancer surgery has increased along with patients’ expectations for a good aesthetic result. The surgery for breast reconstruction can be either be performed at the same operation as the tumour removal or at a later date. Breast reconstruction usually involves an implant or autologous tissue, that is, the patient’s own tissue extracted from elsewhere in the body or a combination of the two.
Lipomodelling has become increasing popular and it uses the patient’s own fat cells to either reconstruct the breast to replace the tissue volume or to fill in defects following breast conserving surgery.
Lipomodelling by liposuction harvests fat by aspiration and a syringe (under general anaesthetic) from the abdomen, bottom or outer thigh. The harvested fat is washed and spun down to isolate the cells / tissue of interest before it is re-injected back into the breast. A breast patient will typically require between 2-4 sessions, i.e. undergoing 2-4 lipomodelling /liposuction procedures with general anaesthetic and this is often in addition to their original breast cancer surgery.
This pilot study aims to determine the safety and efficacy of harvesting a larger volume of fat under the initial lipomodelling (liposuction) procedure and then storing the fat in a dedicated tissue bank for re-injection back into the patient over time (as required) using local anaesthetic.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
13/NE/0330
Date of REC Opinion
20 Dec 2013
REC opinion
Further Information Favourable Opinion